Never miss out an adverse event in the medical record!

A hospital will normally have a policy that identifies all adverse effects that are to be documented in a medical record and those that must be reported to the hospital’s authorities within a specified time frame. An adverse event is defined as “an unanticipated, undesirable, or potentially dangerous adverse effect occurrence” in a hospital (JCI ASH p.246).

Patients are reassessed to determine their response to treatment on medications since they may suffer adverse effects like allergic responses, unanticipated drug/drug interactions, or a change in their equilibrium raising their risk of falls. Therefore, patients are constantly monitored for medication effects including adverse effects through the collaborative efforts between patients themselves, their doctors, nurses, and other health care practitioners (i) to evaluate the medication’s effect on the patient’s symptoms or illness, as well as blood count, renal function, liver function, and other monitoring with select medications, (ii) to observe the patient for adverse effects, and (iii) to record in the patient’s medical record any adverse effect(s).

This monitoring process is normally a proactive approach to risk management of a hospital with a formalised program of risk management to investigate and to reduce identified, unanticipated adverse events and other safety risks to patients and staff.

The accreditation process is well known as an effective quality evaluation and management tool designed to create a culture of safety and quality within a hospital. One of the benefits of accreditation is it strives to continually improve patient care processes and results.

If your hospital is already Joint Commission International (JCI) accredited or seeking JCI accreditation status or undergoing re-survey for JCI accreditation status, then the basics of data gathering and preparation includes selection of measures, data collection and aggregation, data analysis and interpretation, dissemination/transmission of findings, taking action, monitoring performance/improvement are all integral to improving safety and quality of care at your hospital. Medication management data collection issues are either addressed during the System Tracer (Data Use) as a shorter survey or during the full System Tracer – Medication Management survey.

I like to draw your attention when individuals like you as a Health Information Management (HIM) / Medical Records (MR) practitioner may be roped in as part of the hospital’s group of participants during the System Tracer (Data Use) survey since you could be considered as “Individuals who are knowledgeable about the information systems available for data collection, analysis, and reporting” (JCI HSPG p.74) or excluded if a shorter survey just for medication management data collection issues are to addressed.

Do take note too that if you are at a hospital which is already JCI accredited or seeking JCI accreditation status or undergoing re-survey for JCI accreditation status, the Medical Record Review Tool (MMRT).will now check for compliance of the JCI Standard MMU.7 which states that “Medication effects on patients are monitored.”, which this post is all about.

Readers, this post on the JCI Standard MMU.7 and all the rest of the standards I have posted using the JCI Hospital Accreditation Standards 4th Edition, concludes all of the necessary and mandatory documentation standards that must be included in a complete medical record. For hospitals not yet on the JCI journey, I think applying all the standards that are mandatory documentation standards using the JCI Hospital Accreditation Standards 4th Edition augurs for high quality medical records documentation standards at any hospital.

References:

  1. Joint Commission International, 2010, Joint Commission International Accreditation Standards For Hospitals (ASH), 4th edn, JCI, USA
  2. Joint Commission International, 2010, Hospital Survey Process Guide (HSPG), 4th edn, JCI, USA

Impossible for a hospital to collect data to measure everything it wants

It is impossible for a hospital to collect data to measure everything it wants due to its limited resources.  Thus, while a hospital may desire to choose which ever clinical processes and outcomes are most important, but I think it is a prerequisite that any hospital must collect data to measure the managerial processes and outcomes which relates to patient demographics and clinical diagnoses based on its mission, patient needs, and services.

The process, procedure, or outcome to be measured for the managerial area which relates to patient demographics and clinical diagnoses is one of the nine managerial measures recommended by the Joint Commission International (JCI) as outlined under the JCI Standard QPS.3.2 which states that “The organization’s leaders identify key measures for each of the organization’s managerial structures, processes, and outcomes.”

The subject of process, procedure and outcome reminds me of the Three Core Process Model, which groups the many processes that take place in any hospital into three core categories: (1) clinical processes, (2) operational or patient flow processes, and (3) administrative processes.

I shall focus on operational or patient flow processes, and administrative processes which concern the managerial processes and outcomes which relates to patient demographics and clinical diagnoses.

Health Information Management (HIM) / Medical Records (MR) practitioners will be familiar with the standardised operational or patient flow processes which includes processes that typically start with registering and admitting of patients during their visit to the hospital or in the course of their stay in the hospital that enable them to access the clinical processes related to diagnosis, treatment, prevention, and palliative care to address their clinical needs. An operational/patient flow process is an example of a managerial process which utilises and collects patient demographics data during the processes available and familiar to HIM / MR  practitioners when:

  1. admitting inpatients for care
  2. for registering outpatients for services
  3. admission directly from the emergency service to an inpatient unit
  4. the process for holding patients for observation in the Emergency department (ED)
  5. how patients are managed when inpatient facilities (beds and/or services) are limited
  6. how patients are managed when no space is available due to ED crowding and high hospital occupancy rates, thereby creating temporary inpatient holding areas (boarding patients) before admitting patients or to admit patients to the appropriate unit

The administrative decision-making core processes occupy two positions in The Three Core Process Model, one above clinical processes and the other below operational or patient flow processes. Decision making, communication, resource allocation, and performance evaluation processes make up the administrative decision-making core processes. These processes are definitely not under the domain of HIM / MR  practitioners, but HIM / MR  practitioners do contribute to administrative decision-making core processes by the hospital’s leaders by providing data, e.g bed statistics for resource allocation, participating in performance evaluation processes from e.g. Medical Records Review data analysis, uniform use of diagnosis and in the procedure codes based on patient record documentation which supports data aggregation and analysis as well implementation of diagnosis-related groups (DRGs) for decision making processes, and when they communicate with care providers about documentation and compliance issues related to the appropriate assignment of diagnosis and procedure codes.

HIM / MR  practitioners will be aware of prevailing mandatory local, national and international guidelines, standards and norms to measure processes related to patient demographics and clinical diagnoses. Nonetheless a hospital’s leaders are finally responsible for making the final selection of targeted measurement activities. The hospital’s leaders will decide and determine the following:

  1. identify the process, procedure, or outcome to be measured
  2. the availability of “science” or “evidence” supporting the measure to reduce unwanted variation in outcomes
  3. how the measurement will be accomplished by deciding the frequency of measurement
  4. how to organise the measurement activities so as to incorporate data collection into daily work processes

Hospital leaders are busy attending to both operating and strategic-level issues that concern quality, but they usually and always put patients first, and they will use data and information to examine and respond to problems, and rely on the participation of the entire workforce including HIM / MR  practitioners as members of the team who must possess a thorough understanding of the processes and the knowledge of specific tools to assess and to improve processes including those related to patient demographics and clinical diagnoses.  HIM / MR  practitioners must work with the hospital’s leaders to constantly seek changes that will co-produce improvement in a continuous cycle while outside regulators for example, the JCI checks on the quality of care of patient care systems and the outcomes they produce.

The measures selected and the analysis of the measurement data must ultimately fit into the hospital’s overall plan for quality measurement and patient safety, when they prove helpful in better understanding or more intensively assessing the areas related to patient demographics and clinical diagnoses that is under study. They also help to formulate strategies for improvement in the area being measured, and subsequent follow-up measures becomes helpful in understanding the effectiveness of the improvement strategy.

References:

  1. Diane, LK 2007, Applying quality management in healthcare : a systems approach, 2nd edn, Health Administration Press, Chicago, Illinois, USA
  2. Joint Commission International, 2010, Joint Commission International Accreditation Standards For Hospitals, 4th edn, JCI, USA
  3. Prathibha, V (ed.) 2010, Medical quality management : theory and practice, 2nd edn,  Jones and Bartlett Publishers, Sudbury, MA, USA

JCI Standard MCI.20.2 – Using or participating in external databases

In order to compare its performance and to identify opportunities for improvement, a Hospital needs a mechanism for comparing its performance to that of other similar hospitals locally, nationally, and internationally with recognised, internationally accepted standards.

The mechanism must be designed to transform input forces and movement by (i) operate or interact by participating in external performance databases, (ii) compare its performance to that of other similar hospitals,  into a desired set of output forces and movement when the hospital can identify opportunities for improvement and hence documenting its performance level.

This arrangement of connected parts in a system of parts of individual hospital performances like those parts of a machine is surely an effective tool to demonstrate the quality and safety that are being provided in the hospital and can be thought of as benchmarks of success when the hospital participates through reference databases.

I can think of the following initiatives in the US when hospitals as providers participate through reference databases to improve by benchmarking their performance against others, encourage private insurers and public programs to reward quality and efficiency, and help patients make informed choices:

  1. Hospital Compare which encourages hospitals to improve the quality of care they provide and for patients to find hospitals and compare the quality of their care  and make decisions about which hospital will best meet their health care needs;
  2. Quality Improvement Organization (QIO) – a private, mostly not-for-profit contractor of the Centers for Medicare & Medicaid Services (CMS) to improve the quality of health care for all Medicare beneficiaries;
  3. ORYX® data reported on The Joint Commission website at Quality Check® which permits user comparisons of hospital performance at the state and national levels; and
  4. hospitals complete The Leapfrog Hospital Survey, the gold standard for comparing hospitals’ performance on the national standards of safety, quality, and efficiency

In all instances, hospitals need to check if they are required by local laws or regulations to contribute to some external databases. Hospitals also need to maintain security and confidentiality of data and information at all times when operating or interacting with external databases.

ff your hospital is a hospital which is already JCI accredited or seeking JCI accreditation status or undergoing re-survey for JCI accreditation statusthen the JCI Standard MCI.20.2 requires it to have a mechanism in place with the following characteristics:

  1. there is a process to participate in or to use information from external databases, thus satisfying the JCI Standard QPS.4.2, ME 2 which states that “Comparisons are made with similar organizations when possible.”;
  2. the hospital contributes data or information to external databases in accordance with laws or regulations, thus satisfying for example both the JCI Standard PCI.10.4, ME 1 which states that “Health care–associated infection rates are compared to other organizations’ rates through comparative databases.” and the JCI Standard QPS.4.2, ME 2; and
  3. the hospital compares its performance using external reference databases, also satisfying the JCI Standard QPS.4.2, ME 2; and the hospital maintains security and confidentiality when contributing to or using external databases.

References:

  1. Facts about ORYX® for Hospitals (National Hospital Quality Measures), The Joint Commission, viewed 8 March 2013, < http://www.jointcommission.org/facts_about_oryx_for_hospitals/ >
  2. Joint Commission International, 2010, Joint Commission International Accreditation Standards For Hospitals, 4th edn, JCI, USA
  3. Prathibha, V (ed.) 2010, Medical quality management : theory and practice, 2nd edn,  Jones and Bartlett Publishers, Sudbury, MA, USA
  4. Quality Improvement Organizations, Centers for Medicare & Medicaid Services, viewed 6 March 2013, < http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityImprovementOrgs/index.html?redirect=/qualityimprovementorgs >
  5. Welcome to the Leapfrog Hospital Survey, The Leapfroggroup, viewed 8 March 2013, < https://leapfroghospitalsurvey.org/ >

Data Validation Process In Summary

Measurement is about selecting what is to be measured, selecting and testing the
measure, collecting the data, validating the data, and using the data for improvement.

Validating the data is an important tool for understanding the quality of the quality data which is reliable, accurate, and defensible data that has been validated, for establishing the level of confidence decision makers can have in using data and in their implications for clinical practice.

An example of performance measurement is when an area for improvement in structure, process, and/or outcome is identified, new guidelines for patient care and safety are usually developed by the hospital using the data which had been selected, tested, collected, validated for patient care and safety improvement. This change process is normally managed by the hospital and include key stakeholders (e.g., clinicians) affected by the change.

An example of data validation when Health Information Management (HIM) / Medical Records (MR) practitioners who are generally specialised or experts is in disease coding may be involved, is when they provide advice in disease coding validation studies to determine staff training needs.

To ensure that a sample is valid when evaluating performance, it is critical to always determine an appropriate sample size ie. the number of subjects to choose, a procedure to ensure that your sample is representative of the population i.e the degree to which the subjects are similar to those in the intended use, and also determine the types of data to be used (administrative or clinical).

Well, you need to sample so as to try to get one that represents the population as closely as possible. This is because we rarely have enough time and money to look at the entire group of people that we are interested in (for example, the population of everyone attending a clinic at a particular hospital).

In trying to getting a valid sample, let us assume you had limited money, you cannot
study the target population as a whole. By all means do select a small sample size but when you choose a small sample size, there is always a higher risk of sampling error being present, for example when you could only choose only two patients out of the population of 30.

Unclear data definitions and inconsistent coding of data are reasons when data elements are found not to be the same. It is vital to have a list of codes with their definitions that you are going to be using throughout the collection of data. For example, if you are coding ward clerk as 1 and charge nurse as 2, it is important to ensure that you have used the same codes throughout the process of entering data into the dataset. In data validation, It is important to make corrective actions when inconsistent coding of data is found. However, if you do decide to change some data codes, it would be wise to note any changes as you progress.

The chart below characterises the process of data validation (by clicking on the chart below, it will open in a new tab of your current window, and by clicking on the image in this new tab, you can view a larger view of the chart).

Data Validation Process

Data validation to ensure that good, useful data have been collected

Anyone who deals with data, will know that data is first acquired (collected) and verified (validated) before data input. Data input is then processed or managed which includes data storage, data classification, data update, and data computation. Data output is when the data input and processed or managed is retrieved and data is presented in a meaningful way.

Data acquisition (collection), data verification (validation), data classification, data storage, data update, data computation, data retrieval and data presentation are the eight elements which make up the three phases when we deal with data, that is the data input phase, the data management or processing phase and lastly, the data output phase.

Data are the raw materials that involves both the generation and the collection of accurate, timely, and relevant data through reliable measurements that ensures good, useful data have been collected.

Good, useful data involves using an internal data validation process in the authentication and validation of gathered data from authoritative, valid, and reliable data sources. It is important to consider applying the garbage in garbage out (GIGO) principle in collecting valid data.

If your hospital is implementing or has already begun a quality improvement program for example the Joint Commission International (JCI) hospital accreditation program, the quality of your hospital’s quality improvement program  is only as valid as the data that you have collected through reliable measurements.

When using data for improvement and for establishing the level of confidence decision makers can have in the data when implementing or starting a quality improvement program, JCI (2011, pg. 156) recommends data validation in these following circumstances :

  • a new measure is implemented (in particular, those clinical measures that are intended to help an
  • hospital evaluate and improve an important clinical process or outcome);
  • data will be made public on the hospital’s Web site or in other ways;
  • a change has been made to an existing measure, such as the data collection tools have changed or the
  • data abstraction process or abstractor has changed;
  • the data resulting from an existing measure have changed in an unexplainable way;
  • the data source has changed, such as when part of the patient record has been turned into an electronic
  • format and thus the data source is now both electronic and paper; or
  • the subject of the data collection has changed, such as changes in average age of patients, comorbidities,
  • research protocol alterations, new practice guidelines implemented, or new technologies and treatment methodologies introduced.

JCI (2011, pg. 157) also recommends the following essential elements of a credible data validation process as an important tool for understanding the quality of the quality data:

  1. re-collecting the data by a second person not involved in the original data collection
  2. using a statistically valid sample of records, cases, and other data; a 100% sample would only be needed when the number of records, cases, or other data is very small
  3. comparing the original data with the re-collected data
  4. calculating the accuracy by dividing the number of data elements found to be the same by the total number of data elements and multiplying that total by 100. A 90% accuracy level is a good benchmark
  5. when data elements are found not to be the same, noting the reasons (for example, unclear data definitions) and taking corrective action
  6. collecting a new sample after all corrective actions have been implemented to ensure the actions resulted in the desired accuracy level

Health Information Management (HIM) / Medical Records (MR) practitioners do take note that ff your hospital is a hospital which is already JCI accredited or seeking JCI accreditation status or undergoing re-survey for JCI accreditation status, then it must integrate data validation into its quality management and improvement processes, has an internal data validation process that includes (1) through (6) above, and the data validation process must include at least the measures selected as required in Standard QPS.3.1 when “The organization’s leaders identify key measures for each of the organization’s clinical structures, processes, and outcomes.” Such identified key measures is usually integrated as an ongoing standardised process to evaluate the quality and safety of the patient services provided by each medical staff member as required by the JCI Standard SQE.11 In other words, each of the hospital’s clinical structures, processes, and outcomes provided by each medical staff member are evaluated, and conclusions drawn from in-depth analysis of known complications of clinical structures, processes, and outcomes as applicable which are in turn used for all corrective actions to be implemented.

References:

  1. Joint Commission International, 2010, Joint Commission International Accreditation Standards For Hospitals, 4th edn, JCI, USA
  2. Joseph, T & Payton, FC, 2010, Adaptive health management information systems : concepts, cases, & practical applications, 3rd edn, Jones and Bartlett Publishers, Sudbury, MA, USA